FDA.reportPublic FDA data

Gallant™

Primary DI
05415067031990
Brand
Gallant™
Company
ST. JUDE MEDICAL, INC.
Model
CDVRA500Q
Catalog number
CDVRA500Q
Device description
VR Implantable Cardioverter Defibrillator VVEV VVIR
Published
2020-09-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LWSImplantable cardioverter defibrillator (non-CRT)
OSRPacemaker/icd/crt non-implanted components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LWSImplantable Cardioverter Defibrillator (Non-Crt)Unknown3
OSRPacemaker/Icd/Crt Non-Implanted ComponentsUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05415067031990PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05415067031990054150670319905415067031990

GMDN Terms#

Term, Definition table
TermDefinition
Single-chamber implantable defibrillatorAn implantable pulse generator with a cardiac rhythm recognition system, to analyse an electrocardiogram (ECG), that delivers an electrical impulse(s) to defibrillate the heart (restore normal rhythm) or slow a rapid heart rate. It is implanted in a pouch beneath the skin of the patient's chest or abdomen and has connected leads that are positioned inside or on one heart chamber (typically a ventricle) to monitor the ECG and to automatically deliver the electrical impulse to treat ventricular fibrillation or tachycardia. The device has internal batteries that provide the energy to deliver the discharges; it is commonly known as an automatic implantable cardioverter-defibrillator (AICD).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Handling Environment Temperature10 Degrees Celsius45 Degrees Celsius
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Handling Environment Temperature50 Degrees Fahrenheit113 Degrees Fahrenheit
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00Keep Dry. Keep Away from Sunlight. Protect From Heat and Radioactive Sources.
Special Storage Condition, Specify00Storage excursions permitted from 59°- 86° F (15°- 30°C).
Storage Environment Temperature10 Degrees Celsius45 Degrees Celsius
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature22 Degrees Celsius22 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit113 Degrees Fahrenheit
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Storage Environment Temperature72 Degrees Fahrenheit72 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
790268031
Device count
1
Serial number
true
Expiration date on label
true

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